Vilobelimab
Generic Name: vilobelimab
Brand Names:
Gohibic
11 DESCRIPTION Vilobelimab is a chimeric human/mouse immunoglobulin G4 (IgG4) antibody consisting of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions), and human gamma 4 heavy chain and kappa light chain constant regions.
Overview
11 DESCRIPTION Vilobelimab is a chimeric human/mouse immunoglobulin G4 (IgG4) antibody consisting of mouse anti-human complement factor 5a (C5a) monoclonal binding sites (variable regions of heavy and light chain regions), and human gamma 4 heavy chain and kappa light chain constant regions.
Dosage
2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosage The recommended dosage of GOHIBIC for the treatment of adults with COVID-19 is 800 mg administered by intravenous infusion after dilution [see Dosage and Administration (2.2) ] for a maximum of 6 (six) doses over the treatment period as described below. Treatment should be started within 48 hours of intubation (Day 1) followed by administration on Days 2, 4, 8, 15 and 22 as long as the patient is hospitalized (even if discharged from ICU). 2.2 Preparation and Administration Preparation Using aseptic technique, dilute and prepare GOHIBIC for intravenous infusion before administration. For the recommended dose of 800 mg GOHIBIC, dilute 80 mL of GOHIBIC in 170 mL of 0.9% Sodium Chloride at room temperature.
Side Effects
6 ADVERSE REACTIONS 6.1 Clinical Trial Experience The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14) ] . The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care.
Interactions
7 DRUG INTERACTIONS No drug interaction studies have been conducted with GOHIBIC.
Warnings
5 WARNINGS AND PRECAUTIONS There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use. 5.1 Serious Infections Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6) ] . 4 CONTRAINDICATIONS No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.
Pregnancy
8.1 Pregnancy Risk Summary There are no available data on GOHIBIC use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as GOHIBIC is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
Storage
Storage and Handling Store unopened vials refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze. Do not shake.
Frequently Asked Questions
What are the side effects of Vilobelimab?▼
6 ADVERSE REACTIONS 6.1 Clinical Trial Experience The following adverse reactions have been observed in the clinical studies of GOHIBIC that supported the EUA. The adverse reaction rates observed in these clinical studies cannot be directly compared to rates in the clinical studies of other products and may not reflect the rates observed in clinical practice. The safety of GOHIBIC is based on PANAMO, a Phase 3 randomized, placebo-controlled trial in COVID-19 patients requiring IMV or ECMO [see Clinical Studies (14) ] . The analysis of adverse reactions included a total of 364 adult patients who received at least one dose of either GOHIBIC (n=175) or placebo (n=189) plus standard of care.
Can I take Vilobelimab during pregnancy?▼
8.1 Pregnancy Risk Summary There are no available data on GOHIBIC use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Placental transfer of monoclonal antibodies such as GOHIBIC is greater during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
What are the important warnings for Vilobelimab?▼
5 WARNINGS AND PRECAUTIONS There are limited clinical data available for GOHIBIC. Serious and unexpected adverse events (AEs) may occur that have not been previously reported with GOHIBIC use. 5.1 Serious Infections Serious infections due to bacterial, fungal, and viral pathogens have been reported in patients with COVID-19 receiving GOHIBIC. In patients with COVID-19, monitor for signs and symptoms of new infections during and after treatment with GOHIBIC. There is limited information regarding the use of GOHIBIC in patients with COVID-19 and concomitant active serious infections. The risks and benefits of treatment with GOHIBIC in COVID-19 patients with other concurrent infections should be considered [see Adverse Reactions (6) ] . 4 CONTRAINDICATIONS No contraindications have been identified based on the limited available data for the emergency use of GOHIBIC under this EUA.
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.